There have been notorious stories involving patients who have undergone erroneous surgical procedures, including amputation and removal of organs. In some instances, the amputation involved the wrong part of the right patient. In other instances, the surgery involved a patient who was not even scheduled for the surgery performed. Unfortunately, the errors giving rise to these stories do occur.
The use of identification bracelets is a method of tracking patients, their conditions, and contraindications. After the bracelets are put on, they have to be cut off. This prevents lost or misplaced bracelets. The bracelets, usually, cannot be placed near the surgical site.
Some hospitals, clinics and doctors now use ad hoc procedures to eliminate such terrible mistakes. In some instances, the medical personnel responsible for preparing patients for surgery will use a marker to denote a surgical site. An approved system is directed to surgeons and is titled, Sign Your Site, which requires the surgeon to mark the surgical site. These markings have some drawbacks because a mark that is not physically close to an incision may be totally covered by surgical draping before the operation; the surgeon may not be present to sign his site until the patient is draped which would result in disturbing the sterile surgical field.
Attempts to diminish the incidence of these errors have been made such as writing “no” on the incorrect extremity or “yes” on the correct extremity, requiring the surgeon to sign the intended incision site, and requiring the surgeon to read the operative consent in addition to personally identifying the patient, etc. These have all helped, but the problem persists.
The American Academy of Orthopaedic Surgeons has undertaken a voluntary campaign to have the surgeon sign the incision site; surgeons in Canada have tried the same approach the result so far has been encouraging, but not yet satisfactory. A recently published study which attempted to enlist the patient to assist in the prevention of wrong-site surgery by signing “yes” in the area he/she expects the incision to be made was a failure due to lack of compliance. The Joint Commission on Accreditation of Healthcare Organizations has wisely required a “time out” prior to starting surgery during which the patient is identified, the “yes” over the incision site is reviewed, and the surgical consent is read. Occasionally, however, the surgical team forgets to take the “time out” or remembers to do it only after the surgery has begun. Also, the “time out” frequently occurs while the surgeon is prepping and draping the operative site—his/her attention may be diverted by the prepping procedure despite the best intentions.
Another source of confusion is that after a thorough review of all the proper information, the patient is occasionally turned over or around (in some instances, while the surgeon is out of the operating room to scrub or check instruments)—right and left are then reversed, and if the change in position is forgotten or unexpected, the incorrect side may be operated upon.
Some safety procedures have attempted to involve the patient in the prevention of wrong-site surgery. In The Journal of Bone & Joint Surgery, Vol. 85-A, No. 5, May 2003, a study of such a procedure was published. The over-all conclusion was that patients were not very responsive to following explicit preoperative instructions to place an indicator, such as YES on one part of the body and NO on a similar part. As mentioned above, some patient marks were not close enough to the site to be useful and some were missing entirely. It seems that the patient becomes too passive in the medical environment and assumes that these details will be correctly executed.
In the computer industry, certain tracking systems employ a micro-chip with a programmable memory that can be subsequently read by a scanner. Such micro-chips are manufactured by Texas Instruments under the name, Tag It Smart Label or TI-RFid. The micro-chip may be incorporated into a “smart card” and may be read by a wireless reader integrated with a PC (personal computer), PDA (personal digital assistant) and/or printer. The tags and readers operate in the 13.56 MHZ range. The chips are used in facility protection and admittance along with asset tracking.
Another computer product is called iButton, by Dallas Semiconductor MAXIM, that has a programmable memory chip in a 16 mm stainless steel disk that may be hosted by a PC, PDA or laptop computer. The disk has an annular flange that serves as the attachment structure. The iButton has a 1-wire reader to transfer data from the chip to a computer. It is also used for admittance, asset tracking and authentication.
The chips in either of these products are capable of storing and retrieving more than enough information to satisfy the needs of medical personnel to correlate a patient with a condition and a surgical procedure to be performed.
What is needed in the art is a safety apparatus that can be programmed with essential information about the patient, the surgical procedure to be performed, and designate a person with responsibility for insuring the programmed information is correct. Accompanying procedure includes the steps of applying the apparatus to the patient, confirming the programming and the site to be corrected, and removing the apparatus.